Overview: The U.S. Food and Drug Administration (FDA) has deemed Stryker’s recall of its ShapeMatch Cutting Guides as a Class I recall. The designation means that the device, which is used in total knee replacements, poses a reasonable risk of serious injury or death. Stryker has discontinued the product in November 2012, and officially recalled in in January.
- The FDA has designation the Stryker recall of its ShapeMatch Cutting Guides as Class I, meaning it poses a risk of serious injury or death
- The recall was issued because the products were not manufactured properly, according to Stryker’s press release
- Stryker has had other recalls of its devices, including metal-on-metal hip implants and the Neptune waste management system
Product: ShapeMatch Cutting Guides
Recalled Device has Risk of Serious Injury, Death
Stryker’s ShapeMatch Cutting Guides are used to by surgeons to help position the knee replacement components during a total knee replacement; it is also used to guide marking of the bone before cutting. According to a press release by Stryker, the company had initially told surgeons to stop used the devices last November. In January, the company officially recalled the products “due to the potential that ShapeMatch Cutting Guides may not have been manufactured in accordance with surgeon preoperative planning parameters or may have been manufactured outside of the planning ranges specified in the 510(k) clearance.” Yesterday, the company announced that the FDA classified that recall as Class I. A Class I recall is the FDA’s most serious recall status; it means that exposure to the product poses a reasonable risk of serious injury or death.
This is not the first time regulators have taken issue with the safety of Stryker’s products. Last fall, the company recalled two metal-on-metal hip implants, the Rejuvenate and ABG II, due to a risk of corrosion. FiercePharma reports that Stryker ended up spending about $133 million in the fourth quarter to handle the fallout. The cost of litigation and revision surgeries for the all-metal hip devices could amount to $390 million, Stryker has said. Last month, the FDA also issued a warning letter with regards to how Stryker handed the recall of its Neptune waste management, which also had a Class I designation. The agency had said that it was continuing to receive additional injury reports related to the systems.